CONNECTORRecalls & reported problems across all models

We found 2 models of CONNECTOR by Orthofix US LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CONNECTOR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 23, 2018Terminated

   Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.

   Z-1364-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Feb 23, 2018Terminated

   Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.

   Z-1363-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

CONNECTOR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CONNECTOR 79-2002

  Posterior cervical screw system
  1 recall0 reports
• CONNECTOR 79-2003

  Posterior cervical screw system
  1 recall0 reports

Other Orthofix US LLC products

• FORZA PTC76 models · 3 reports · 1 recall
• Firebird SI Fusion20 models · 1 reports · 1 recall
• CONSTRUX - MINI PTC70 models · 0 reports · 1 recall
• PILLAR SA PTC16 models · 0 reports · 1 recall
• FORZA Ti91 models · 0 reports · 1 recall
• CONSTRUX - MINI Ti112 models · 0 reports · 1 recall
• PILLAR SA Ti3 models · 0 reports · 1 recall